FDA正式发布2018年医疗器械收费标准,年费为USD4,624
来源:    发布时间: 2017-08-28 23:39   7210 次浏览   大小:  16px  14px  12px

2017年8月28日,上海曼通从美国FDA获得最新消息,FDA 公布了2018财年医疗器械收费标准为USD4,624,比2017年的USD3,382上涨36.93%

所有国内的医疗器械生产型和贸易型企业均需要交纳此费用。

上海曼通将从10月1日起为中国用户提供FDA医疗器械注册更新服务。

以下是FDA2008年以来,开始收取医疗器械年费的历年费用标准。可以看到,从2008年的USD1,706到2018年的USD4,624,上涨近3倍。



 


FDA2018财年(2017年10月1日 – 2018年9月30日)主要费率如下:

项目

2018财年

2018财年医疗器械年度费用    

USD4,624/个制造商

2018财年FDA510(K)审核费

USD10,542/个申请

USD2,636/个申请(小规模企业)



你是否遇到以下问题而无法办理FDA更新续费呢?

------如系统用户名中密码忘记;

------员工离职资料未交接;

------原来是委托客户或其它人注册的现在想自己办理注册更新;

------......

没有关系,只要有相关问题,请联系上海曼通客服热线:021-5102-9925,我们的专业人员会为你提供免费咨询服务,和专业的FDA注册代理及更新服务


附:FDA 2018财年医疗器械全部收费标准如下:

https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm573383.htm


FY 18 User Fees(in U.S. Dollars)

Application Type

Standard Fee

Small Business Fee

510(k)

$10,542

$2,636

513(g)

$4,186

$2,093

De Novo classification

$93,017

$23,254

PMA, PDP, PMR, BLA

$310,058

$77,515

panel-track supplement

$232,544

$58,156

180-day supplement

$46,509

$11,627

real-time supplement

$21,704

$5,426

BLA efficacy supplement

$310,058

$77,515

PMA annual report

$10,852

$2,713

30-day notice

$4,961

$2,481

 For smallbusinesses with an approved SBD.

 Note: alltypes of 510(k)s (Traditional, Abbreviated, and Special) are subject to theuser fee. However, there is no user fee for 510(k)s submitted to the FDA onbehalf of an FDA-accredited third-party reviewer.

Smallbusinesses with an approved SBD with gross receipts or sales of $30 million orless are eligible to have the fee waived on their first PMA, PDP,PMR, or BLA.

AnnualEstablishment Registration Fee: $4,631

There are nowaivers or reductions for small establishments, businesses, or groups – allestablishments must pay the establishment registration fee.